FIVE-YEAR SAFETY AND EFFICACY OF GOLIMUMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE PRIOR TREATMENT WITH METHOTREXATE: FINAL STUDY RESULTS OF THE PHASE 3, RANDOMIZED PLACEBO-CONTROLLED GO-FORWARD TRIAL
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Keystone, E. | - |
dc.contributor.author | Genovese, M. C. | - |
dc.contributor.author | Hall, S. | - |
dc.contributor.author | Miranda, P. C. | - |
dc.contributor.author | Bae, S. -C. | - |
dc.contributor.author | Han, C. | - |
dc.contributor.author | Gathany, T. | - |
dc.contributor.author | Zhou, Y. | - |
dc.contributor.author | Xu, S. | - |
dc.contributor.author | Hsia, E. C. | - |
dc.date.accessioned | 2021-08-03T11:35:01Z | - |
dc.date.available | 2021-08-03T11:35:01Z | - |
dc.date.created | 2021-07-23 | - |
dc.date.issued | 2013-10-25 | - |
dc.identifier.issn | 0003-4967 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/46417 | - |
dc.description.abstract | Objectives Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX in a phase 3 trial (GO-FORWARD) of pts with active rheumatoid arthritis (RA) despite MTX therapy are reported. Methods Pts were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 16 (blinded early escape) or 24 (crossover). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, MTX and corticosteroid use could be adjusted, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted based on investigator judgment. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Results A total of 444 pts were randomized; 313 pts continued treatment through wk252, and 131 pts withdrew (64 for AE, 25 for lack of efficacy, 1 protocol violation, 6 lost to follow-up, 32 for other reasons, 3 deaths). 301 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk256, 76.0% of all pts had an ACR20, 89.5% had a DAS28-CRP EULAR response, and 68.5% had improvement in HAQ-DI ≥0.25. Changes from baseline in mean total vdH-S scores were small; 54% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of pts had an injection-site reaction. Through wk268, 172/434 pts (39.6%) had an SAE; 14.1% of pts discontinued study agent due to AEs. The rates of serious infections, malignancies, and death were 11.5%, 6.2%, and 1.8%, respectively. Of 429 pts with available samples, 33 (7.7%) were positive for antibodies to GLM. Conclusions The retention rate was high (70.5%), and improvements in signs/symptoms of RA and in physical function with GLM+MTX therapy were maintained long-term. Radiographic progression appeared controlled with small changes in mean vdH-S scores observed through 5yrs. The long-term safety of GLM is consistent with other anti-TNFα agents. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMJ PUBLISHING GROUP | - |
dc.title | FIVE-YEAR SAFETY AND EFFICACY OF GOLIMUMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE PRIOR TREATMENT WITH METHOTREXATE: FINAL STUDY RESULTS OF THE PHASE 3, RANDOMIZED PLACEBO-CONTROLLED GO-FORWARD TRIAL | - |
dc.title.alternative | Final 5-Year Safety and Efficacy Results Of a Phase 3, Randomized Placebo-Controlled Trial Of Golimumab In Patients With Active Rheumatoid Arthritis Despite Prior Treatment With Methotrexate | - |
dc.type | Conference | - |
dc.contributor.affiliatedAuthor | Bae, S. -C. | - |
dc.identifier.wosid | 000331587904684 | - |
dc.identifier.bibliographicCitation | 2013 ACR/ARHP Annual Meeting, pp.867 - 868 | - |
dc.relation.isPartOf | 2013 ACR/ARHP Annual Meeting | - |
dc.relation.isPartOf | ANNALS OF THE RHEUMATIC DISEASES | - |
dc.citation.title | 2013 ACR/ARHP Annual Meeting | - |
dc.citation.startPage | 867 | - |
dc.citation.endPage | 868 | - |
dc.citation.conferencePlace | US | - |
dc.citation.conferencePlace | San Diego, CA. | - |
dc.citation.conferenceDate | 2013-10-25 | - |
dc.type.rims | CONF | - |
dc.description.journalClass | 1 | - |
dc.identifier.url | https://ard.bmj.com/content/72/Suppl_3/A867.3 | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.